Ongoing Investigation: REGENXBIO Inc. (RGNX) May Have Misled Shareholders - Levi & Korsinsky Investigates

Core Viewpoint - REGENXBIO Inc. is under investigation for potential violations of federal securities laws following the FDA's clinical holds on its RGX-111 and RGX-121 programs, which resulted in a significant decline in the company's share price by 30-35% after the announcement [1]. Regulatory Compliance - SEC disclosure rules mandate that public companies must provide material information for informed investment decisions, with Item 8.01 of Form 8-K allowing disclosure of material events not covered by other items [2]. - Rule 10b-5 under the Securities Exchange Act of 1934 prohibits material misstatements and omissions in securities transactions, covering both false statements and omissions of necessary facts [2]. Company Communication - During the Q3 2025 earnings call, CEO Curran Simpson highlighted positive regulatory interactions, noting that the FDA completed inspections with no observations, which may have created an asymmetric view of the company's regulatory status by not disclosing safety concerns being evaluated [3]. - The Q3 2025 earnings call transcript notably lacked any discussion regarding the RGX-111 program for MPS I, despite it being a significant pipeline asset that later faced the same FDA clinical hold, raising concerns about the completeness of information provided to shareholders [4].